First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors

July 23, 2026 updated by: Adcendo ApS

A First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors

The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Scientia Clinical Research
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Southern Oncology Clinical Research Unit
    • Victoria
      • Clayton, Victoria, Australia, 3165
        • Recruiting
        • Monash Health
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of solid tumor
  • Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
  • Radiologically or clinically determined progressive disease during or after most recent line of therapy
  • Measurable disease per RECIST 1.1
  • ECOG performance status of 0 or 1
  • Adequate hematological and biochemical parameters
  • A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
  • A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment

Exclusion Criteria

  • Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
  • Prior treatment with an ADC containing a topoisomerase I inhibitor payload
  • Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
  • Other malignancy
  • Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
  • Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
  • Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1
  • Clinically significant cardiovascular disease
  • Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
  • Current active liver disease due to hepatitis B or hepatitis C
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ADCE-B05
Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle
Drug: ADCE-B05
Biological: Antibody-drug conjugate (ADC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the MTD/maximum administered dose of ADCE-B05
Time Frame: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)
Incidence of dose-limiting toxicities (DLTs)
From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)
Assess the safety and tolerability of ADCE-B05
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0).

Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation
Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
The maximum concentration (Cmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to maximum concentration (Tmax)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
The time to maximum concentration (Tmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Terminal half-life (T[1/2])
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
The terminal half-life (T[1/2]) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Area under the concentration-time curve (AUC)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
The area under the concentration-time curve (AUC) will be assessed to characterize PK profile of ADCE-B05
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Total antibody (TAb)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
The total antibody will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Free (de-conjugated) payload
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
The free (de-conjugated) payload will be assessed to characterize PK profile of ADCE-B05
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Objective response rate (ORR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Objective response rate (ORR) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Duration of response (DOR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Duration of response DOR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Progression-free survival (PFS)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Progression-free survival (PFS) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Disease Control Rate (DCR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
DCR will be assessed by investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to Response (TTR)
Time Frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
TTR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Throughout the trial duration, completion expected approximately 18 months from completed enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adcendo ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADCE-B05-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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